FRESNO, Calif. (CN) – A woman can proceed with a product-liability lawsuit against a generic drug manufacturer, even though it used the same labeling as the original drug, a California appeals court ruled.
Carlyne McKenney sued Purepac Pharmaceutical Co. after she contracted tardive dyskinesia from her use of the drug Reglan.
The trial court had ruled that McKenney’s claims were pre-empted by federal law because Purepac is not the original manufacturer.
On appeal, Justice Ardaiz reversed the decision, citing the FDA’s own contention that its regulations “will not pre-empt all state law actions.”
Also, Purepac did have some room to revise its drug labeling, according to the judge. If a drug manufacturer “believes that new safety information should be added, it should provide adequate supporting information to the FDA.”